DGFT Committee Minutes

UDIN00158429AM23

Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE (DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/May/202223/4 DATED: 17/06/2022

Please Note

• I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in

• II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.

• III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/May/202223/4 dated 17/06/2022 of Norms Committee - III for the year 2022-23 was held on 17/06/2022 under the Chairmanship of Amiya Chandra,Additional DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No.	Name and Designation of Representatives	Department
1	AJAY KUMAR,Deputy Director	Directorate General of Foreign Trade, Delhi
2	SHAISH KUMAR,Technical Authority	Technical Consultant,DGFT
3	DINESHNARAIN MATHUR,Technical<br>Authority	Technical Consultant,DGFT

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 20-Jul-2022 13:06:31 Date: 20-Jul-2022 1f%06:31 Reason: AJAY.DHIMAN88@GOV.IN Reason: AJAY. IAN88@GOV.IN Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 20-Jul-2022.

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Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000357AM23
RA File Number	522404000019 AM17
Licence No and<br>Date	5210041935/17/06/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and it was decided to revise adhoc norms as under<br>:<br>RA concerned may take further necessary action as per above decision of NC.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>META CHLORO ANILINE<br>0.88 kg<br>2<br>1,3-BROMO CHLORO PROPANE 99%<br>MIN.<br>1.045 kg<br>1-(3-CHLORO PHENYL ) 4-(3-<br>CHLORO PROPYL) PIPERAZINE<br>HCL<br>1 kg<br>3<br>BIS-(2-CHLORO ETHYL) AMINE HCL<br>1.16 kg

Case No.	2 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000358AM23
RA File Number	522404000050 AM18
Licence No and<br>Date	5210042446/04/12/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and it was decided to revise adhoc norms as under<br>:<br>Sl.<br>Export product<br>Qty.<br>Import items<br>Qty.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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		No.
1-(3-CHLORO PHENYL ) 4-(3-<br>CHLORO PROPYL) PIPERAZINE<br>HCL	<br>1 kg	1	META CHLORO ANILINE	0.88 kg
		2	1,3-BROMO CHLORO PROPANE 99%<br>MIN.	<br>1.045 kg

RA concerned may take further necessary action as per above decision of NC.

Case No.	3 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000359AM23
RA File Number	522404000058 AM18
Licence No and<br>Date	5210042463/22/12/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and it was decided to revise adhoc norms as under<br>:<br>RA concerned may take further necessary action as per above decision of NC.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>META CHLORO ANILINE<br>0.88 kg<br>1-(3-CHLORO PHENYL ) 4-(3-<br>CHLORO PROPYL) PIPERAZINE<br>HCL<br>1 kg<br>2<br>1,3-BROMO CHLORO PROPANE 99%<br>MIN.<br>1.045 kg

Case No.	4 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	AMI ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000347AM23
RA File Number	522404000085 AM18

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Licence No and 5210042570/20/03/2018 Date Norms Committee Decision:

The Committee considered the request of firm for review of norms and it was decided to revise adhoc norms as under :

Export	product		Qty.	Sl. No.	Import items	Qty.
TERT-	BUTYL	1-PIPERAZINE	<br>1 kg	1	DI- Tert Butyl Dicarbonate	2.00 kg
CARBOXYLATE (1-BOC		PIPERAZINE)
				2	PIPERAZINE ANHYDROUS	0.80 kg

Case No.	Case No.	5 / NC/3/MEET/May/202223/4	5 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		ATUL LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>018205001846AM19
RA File Number		082404000030 AM19
Licence No and<br>Date		0810142955/04/07/2018
Norms Committee Decision:
The Committee		considered the case	as per agenda and it was		decided to ratify adhoc		norms under		Para 4.07 of HBP
Vol. I as per details given below or			as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items				Qty.
	Formulated	Aromatic<br>Amine1	<br>300000.00 kg	1	Aniline / Aniline Oil				241200.00 kg
	(containing	74.7%<br>Aromatic
	Amine, 11.8% Di Ethyl Toluene<br>Diamine and 13.5% Iso Phoron		<br>	2	Methanol				51600.00 kg
	Diamine)
				3	Di<br>Ethyl	Toluene	Diamine	/	<br>35400.00 kg
					Ethacure 100 / Lonzacure DETDA
					80 / DETDA	80 / DETDA

Case No.	Case No.	5 / NC/3/MEET/May/202223/4	5 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		ATUL LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>018205001846AM19
RA File Number		082404000030 AM19
Licence No and<br>Date		0810142955/04/07/2018
Norms Committee Decision:
The Committee		considered the case	as per agenda and it was		decided to ratify adhoc		norms under		Para 4.07 of HBP
Vol. I as per details given below or			as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items				Qty.
	Formulated	Aromatic<br>Amine1	<br>300000.00 kg	1	Aniline / Aniline Oil				241200.00 kg
	(containing	74.7%<br>Aromatic
	Amine, 11.8% Di Ethyl Toluene<br>Diamine and 13.5% Iso Phoron		<br>	2	Methanol				51600.00 kg
	Diamine)
				3	Di<br>Ethyl	Toluene	Diamine	/	<br>35400.00 kg
					Ethacure 100 / Lonzacure DETDA
					80 / DETDA	80 / DETDA

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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	4	Iso Phoron Diamine / Vestamine	<br>40500.00 kg
		IPD / Baxxodur EC 201 / Wanamine
		IPDA

Case No.	6 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000196AM23
RA File Number	342404000094 AM19
Licence No and<br>Date	3410044399/08/08/2018
Norms Committee Decision:
The Committee considered the request of firm for review of norms and it was observed that the yield indicated is 70.17%,
which seems to be low. Hence, the Committee decided to call for following information / documents from the firm:
Production / Consumption data for last two years duly certified by GST Authorities

Case No.	7 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	NATURAL REMEDIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000342AM23
RA File Number	072404000170 AM19
Licence No and<br>Date	0710113897/25/09/2018
Norms Committee Decision:
The Committee considered the request of firm for review of norms and it was decided to call for following information /
documents from
(i)Complete specification and COA of import item, indicating impurity profile from foreign supplier.
(ii) Production / Consumption data duly certified by GST.
(iii) Net weight of export product.
(iv) Use of Export Product.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	8 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	VARAHI PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001090AM19
RA File Number	NA
Licence No and<br>Date	NA
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I for Advance Authorization No. 6610000013 dated 03.10.2018 having RLA F. No. 662404000004AM19, as per<br>details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>3-METHYL 4-NITRO BENZOIC ACID<br>1.28 kg<br>2<br>4-METHYL 2-CYANO BIPHENYL<br>0.80 kg<br>TELMISARTAN<br>1 kg<br>3<br>POLY PHOSPHORIC ACID<br>1.49 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.<br>	9 / NC/3/MEET/May/202223/4
Case Status<br>	Case Deferred
Party Name<br>	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>	HQRNORM REVIW00000392AM23
RA File Number<br>	039404000496 AM20
Licence No and<br>Date<br>	0310831890/27/09/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and it was decided to call for following information /<br>documents from the firm:<br>Production / Consumption data for last three years duly certified by GST Authorities

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	10 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	AVIK PHARMACEUTICAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000393AM23
RA File Number	039404000497 AM20
Licence No and<br>Date	0310831894/27/09/2019
Norms Committee Decision:
The Committee considered the request of firm for review of norms and it was decided to call for following information /
documents from the firm:
Production / Consumption data for last three years duly certified by GST Authorities

Case No.<br>11 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>018205000719AM20
RA File Number<br>052404000377 AM20
Licence No and<br>Date<br>0510412070/10/10/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product<br>Qty.<br>Sl. No. Import items	Qty.
Deferoxamine Mesylate Sterile<br>1 kg<br>1<br>Deferoxamine Mesylate USP (Non-Sterile)	1.02 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	12 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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and Date
HQ File Number	018205000763AM20
RA File Number	052404000375 AM20
Licence No and<br>Date	0510412231/23/10/2019
Norms Committee Decision:
The Committee considered the request of firm for review of norms and it was decided to call for following information /
documents from the firm:
	(i) Complete composition of Export item No. 2 and 3 indicating percentage of Citrus
	Aldehyde and Natural Waxes.
	(ii) Percentage concentration of export.

a	nd Date
H	Q File N	umber		018205000763AM20
R
	A File N	umber		052404000375 AM20
L<br>D	icence N<br>ate	o and		0510412231/23/10/2019
N<br>T<br>d<br>	orms Co	mmittee Decision:
	he Comm<br>ocuments	ittee considered the request of firm for review of norms and it was decided to call for<br>from the firm:							following information /
		(i) Complete composition of Export item No. 2 and 3 indicating<br>Aldehyde and Natural Waxes.							percentage of Citrus
		(ii) Percentage concentration of export.
C	ase No.			13 / NC/3/MEET/May/202223/4
C	ase Statu	s		Case Approved
P	arty Nam	e		ATUL LIMITED
M<br>a
	eeting N<br>nd Date	umber		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
H	Q File N	umber		018205000812AM20
R	A File N	umber		082404000258 AM20
L<br>D	icence N<br>ate	o and		0810146544/13/11/2019
N<br>T<br>V	orms Co	mmittee Decision:
	he Com<br>ol. I as	mittee considered the case as per agenda and it was decided to ratify adhoc norms un<br>per details given below or as applied by the firm, whichever is less:							der Para 4.07 of HBP
	Export p	roduct			Qty.	Sl. No.	Import items			Qty.
	Formula<br>(contain	ted<br>Aromatic<br>Amine1<br>ing<br>74.7%<br>Aromatic			<br> <br>300000.00 kg	1	Aniline / Aniline Oil			241200.00 kg
	Amine,<br>Diamine<br>Diamine	11.8% Di Ethyl Toluene<br>and 13.5% Iso Phoron<br>)			<br>	2	Methanol			51600.00 kg
						3	Di<br>Ehl<br>Tl<br>Dii		<br>/	<br>3540000 k
							<br>ty<br>ouene<br>amne<br> <br>Ethacure 100 / Lonzacure DETDA<br>80 / DETDA 80 / DETDA			<br> <br>. g
										<br>
						4	Iso Phoron Diamine / Ves<br>IPD<br>/<br>Baxxodur<br>EC<br>Wanamine IPDA	tamine<br>201<br>/		<br> <br>40500.00 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	14 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205000821AM20
RA File Number	318304000104 AM20
Licence No and<br>Date	3110067591/15/11/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Doxycycline Hyclate Grade-BP<br>0.202 kg<br>1<br>Tylodox-Gold WSP (Tylosin and<br>Doxycycline Water Soluble Powder)<br>1 kg<br>2<br>Tylosin Tartrate (VET)<br>0.101 kg<br>2<br>Neodox-Gold WSP (Doxycycline<br>and<br>Neomycin<br>Water<br>Soluble<br>Powder)<br>1 kg<br>1<br>Doxycycline Hyclate Grade-BP<br>0.101 kg<br>3<br>AmpKO-50<br>(Amprolium<br>Soluble<br>Powder USP 50% W/W)<br>1 kg<br>3<br>Amprolium HCL-USP<br>0.505 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	15 / NC/3/MEET/May/202223/4
Case Status	Case Rejected
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205000828AM20
RA File Number	039404000628 AM20

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Licence No and 0310832799/15/11/2019 Date Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply. Hence, the Committee decided to reject the case.

Case No.	16 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	RENOWN PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001018AM20
RA File Number	342404000326 AM20
Licence No and<br>Date	3410045792/17/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>SOFT GELATIN CAPSULES<br>(ITC (HS) CODE 30045090 / 30045039 )<br>(NET CONTENT : 1) GELATIN 175 BLOOM<br>5-15 MESH : 20395.922 KILOGRAM)<br>72325965<br>Number<br>1<br>GELATIN 175 BLOOM 5-15<br>MESH<br>22436 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	17 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001022AM20
RA File Number	052404000669 AM20
Licence No and	0510413373/17/01/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the information given by the firm is incomplete. The yields now given are low and do not match with reactionsequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm for attending Personal Hearing before Norms Committee to explain its case.

Case No.<br>18 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>MAGNOLIA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>018205001551AM21
RA File Number<br>039504001071 AM20
Licence No and<br>Date<br>0310834718/07/02/2020
Norms Committee Decision:
The Committee considered the case as per agenda	and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Feb/202122/14 dated	21.02.2022 against advance authorization No.0311004164 dt.
31.05.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by
the firm, whichever is less:
Export Product<br>Qty.	Sl. No. Import items	Qty.
5-(1H-Pyrrol-1-yl)-2-<br>1 kg	1<br>2-Mercapto-5-Methoxy	0.898 kg
Mercaptobenzimidazole	Benzimidazole
RA concerned may take further necessary action as per above decision of NC.

Case No.	19 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001599AM21
RA File Number	052404000742 AM20
Licence No and<br>Date	0510413763/02/03/2020
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
VALPROIC ACID	1 kg	1	DIETHYL MALONATE	1.42 kg
		2	N-PROPYL BROMIDE	2.186 kg
		3	SODIUM HYDROXIDE FLAKES	0.88 kg
		4	TETRA BUTYL AMMONIUM BROMIDE	0.100 kg
		5	SULPHURIC ACID	Not an importable
				item

Case No.	Case No.	20 / NC/3/MEET/May/202223/4	20 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		018205001129AM20
RA File Number		039504001078 AM20
Licence No and<br>Date		0310835280/06/03/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product	Qty.	Sl. No.	Import items	Qty.
	ISOBORNYL ACETATE<br>50000 kg		1	GUM TURPENTINE OIL	47645 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	21 / NC/3/MEET/May/202223/4	21 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001142AM20
RA File Number	342404000343 AM20
Licence No and<br>Date	3410045953/12/03/2020
Norms Committee Decision:
The Committee considered the case		as per agenda and it was		decided to ratify adhoc norms under	Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product		Qty.	Sl. No.	Import items	Qty.
METHYL<br>2-METHOXY<br>5		<br>60000.00 kg	1	METHYL SALICYLATE	60000.00 kg
SULFAMOYL	BENZOATE
(MSMB)
			2	DIMETHYL FORMAMIDE	106800.00 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>22 / NC/3/MEET/May/202223/4
Case Status<br>Case Deferred
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>018205001136AM20
RA File Number<br>052404000749 AM20
Licence No and<br>Date<br>0510413850/12/03/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the
information given by the firm is incomplete. The yields now given are low and do not match with reaction-
sequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm
for attending Personal Hearing<br> before Norms Committee to explain its case.

The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the information given by the firm is incomplete. The yields now given are low and do not match with reactionsequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm for attending Personal Hearing before Norms Committee to explain its case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

13

UDIN00158429AM23

Case No.	23 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001143AM20
RA File Number	342404000389 AM20
Licence No and<br>Date	3410045957/13/03/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>METHYL SALICYLATE<br>1.11 kg<br>2-METHOXYBENZOIC ACID<br>1 kg<br>2<br>DIMETHYL SULPHATE<br>0.92 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	24 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001264AM21
RA File Number	052404000025 AM21
Licence No and<br>Date	0510414108/06/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the norms for subject Advance<br>Authorization have already been ratified by NC-3 in its Meeting No.NC/3/MEET/Jan/202021/4dated12.02.2021.<br>In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that the norms for subject Advance Authorization have already been ratified by NC-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 .

Case No.	25 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

14

UDIN00158429AM23

Meeting Number<br>and Date	Meeting Number<br>and Date	Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			018205001314AM21
RA File Number			318304000009 AM21
Licence No and<br>			3110067742/21/05/2020
Date
Norms Committee			ecision:
The Committee co<br>Vol. I as per detai			nsidered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>ls given below or as applied by the firm, whichever is less:
	Sl. No.	Export p	roduct	Qty.		Sl. No.	Import items				Qty.
	1	TYLODOX GOLD POWDER<br>1Kg Jar Tylosin & Doxycycline<br>Water Soluble Powder		<br> <br>1 Number		1	DOXYCYCLINE<br>HYCLATE<br>DOXYCYCLINE HYCLATE GRADE BP				<br>202 grams
						2	TYLOSIN TARTRATE<br>				101 grams
							T	YLOSIN T	ARTRATE VET IP/EP/B	P
	2	TYLODOX GOLD POWDER<br>100 GMS Sachet Tylosin &<br> <br> <br>		<br> <br> <br>1 Number		1	D<br>D	OXYCYC<br>OXYCYC	LINE<br>H<br>LINE HYCLATE GRAD	YCLATE<br>E BP	<br>20.20<br>grams
		Doxycycline<br>Water<br>Soluble<br>Powder
						2	T<br>T	YLOSIN T<br>YLOSIN T	ARTRATE<br>ARTRATE VET IP/EP/B	P	10.10<br>grams
	3	NEODOX GOLD POWDER<br>1KG<br>Jar<br>Neomycin<br>&		<br> <br>1 Number		1	D<br>D	OXYCYC<br>OXYCYC	LINE<br>H<br>LINE HYCLATE GRAD	YCLATE<br>E BP	<br>101.00<br>
		<br> <br> <br> <br>Doxycycline Soluble Powder									grams
	4	NEODOX GOLD POWDER<br>100GMS Sachet Neomycin &		<br> <br>1 Number		1	DOXYCYCLINE<br>HYCLATE<br>DOXYCYCLINE HYCLATE GRADE BP				<br>10.10<br>rams
		<br>Doxycycline Soluble Powder									g
RA concerned may			take further necessary action as per above decision of NC.
Case No.			26 / NC/3/MEET/May/202223/4
Case Status			Case Deferred
Party Name			SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			HQRNORM REVIW00000385AM23
RA File Number			022404000012 AM21

Case No.	26 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000385AM23
RA File Number	022404000012 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

15

UDIN00158429AM23

Licence No and<br>Date	0210209889/29/05/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
COA of import item from foreign supplier for the relevant import.<br>i.
Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	27 / NC/3/MEET/May/202223/4
Case Status	Case Rejected
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001382AM21
RA File Number	039404000156 AM21
Licence No and<br>Date	0310836662/15/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and reply of firm and it was observed that the firm has not given any
technical details in	its reply.
In view of above, the Committee decided torejectthe case.

The Committee considered the case as per agenda and reply of firm and it was observed that the firm has not given any technical details in its reply.

Case No.	Case No.	28 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		018205001388AM21
RA File Number		082404000062 AM21
Licence No and<br>Date		0810147963/17/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was				decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product	Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

16

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CEFABACT INJECTION 1 gm (NO 1 Number 1 CEFOTAXIME SODIUM STERILE 1.079 gram SWFI but 20ml vial) (Individual USP - THIS AUTHORISATION Cartoon Packing)(NET CONTENTS ISSUED AS PER POLICY OF BULK DRUG SHOULD NOT CIRCULAR No.9 BE LESS THAN 250 KGS IN THE RESULTANT PRODUCT AND SHOULD BE SHOWN IN EXPORT DOCUMENTS.)

RA concerned may take further necessary action as per above decision of NC

R	CEFABACT INJECTION 1 gm (NO<br>SWFI but 20ml vial) (Individual<br>Cartoon Packing)(NET CONTENTS<br>OF BULK DRUG SHOULD NOT<br>	CEFABACT INJECTION 1 gm (NO<br>SWFI but 20ml vial) (Individual<br>Cartoon Packing)(NET CONTENTS<br>OF BULK DRUG SHOULD NOT<br>	1 Number	1 Number	1 Number	1	1	CEFOTAXIME SODIUM STERILE<br>USP - THIS AUTHORISATION<br>ISSUED<br>AS<br>PER<br>POLICY<br>CIRCULAR No.9	CEFOTAXIME SODIUM STERILE<br>USP - THIS AUTHORISATION<br>ISSUED<br>AS<br>PER<br>POLICY<br>CIRCULAR No.9	CEFOTAXIME SODIUM STERILE<br>USP - THIS AUTHORISATION<br>ISSUED<br>AS<br>PER<br>POLICY<br>CIRCULAR No.9	<br> <br> <br>1.079 gram	<br> <br> <br>1.079 gram
	BE LESS THAN 250 KGS IN THE<br>RESULTANT<br>PRODUCT<br>AND<br>SHOULD BE SHOWN IN EXPORT<br>DOCUMENTS.)
	A concerned may take further necessar		y action a
					s per ab		ove decision of NC
C	ase No.	29 / NC/3/MEET/Ma	y/202223/		4
Case Status		Case Approved
Party Name		YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		018205001426AM21
RA File Number		039504000182 AM21
Licence No and		0310836907/26/06/2020
Date
Norms Committee<br>Th Ci		Decision:<br>idd h d d ki f li dii f d i
e ommttee co<br>Meetin No7/82-		nsere te case as per agena an tang cue rom earer ecson or same export prouct n<br>LC4/2020dated 04122020aainst advance authorization No0310825514dt 07122018it was
g .<br>decided to ratify n		.. g<br>rms under Para 407 of HBP Vol I as					. . ..,<br>per details given below or as applied by the firm whichever
<br>is	<br>less:	. .					,
	Export Product<br>Qty.
				Qty.			Sl. No.		Import items			Qty.
	YANTQ 3030	B ( 30% SOLUTION OF		<br>1 k			1		HYDROQUINONE			0423 k
	<br>TERTIARY B	<br>UTYL HYDROQUINONE)		<br> <br>g								. g
	<br>in Propylene Gl	<br>ycol
							2		TERTIARY BUTANOL			0.312 kg
							3		PROPYLENE GLYCOL			0.700 kg
RA concerned may take further necessary action as per above decision of NC.
Case No.		30 / NC/3/MEET/May/202223/4

Case No. 30 / NC/3/MEET/May/202223/4

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

17

UDIN00158429AM23

Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000388AM23
RA File Number	022404000050 AM21
Licence No and<br>Date	0210210010/27/07/2020
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
COA of import item from foreign supplier for the relevant import.<br>i.
Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	31 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	AMINES AND PLASTICIZERS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001625AM21
RA File Number	039404000370 AM21
Licence No and<br>Date	0310838163/08/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Percentage yield of reaction.<br>i.

Case No.	32 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	VISWAAT CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001627AM21
RA File Number	039504000327 AM21
Licence No and<br>Date	0310838181/09/09/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP

The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

18

UDIN00158429AM23

Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
VICASOL<br>MV<br>01<br>[DIETHANOL<br>ISOPROPANOL AMINE] DEIPA	<br>1 kg	1	DIETHANOL AMINE [DEA]	0.617 kg
		2	PROPYLENE OXIDE	0.383 kg

Case No.	33 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001663AM21
RA File Number	072404000163 AM21
Licence No and<br>Date	0710117014/15/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete and balanced chemical reactions with molecular of each reactant, molar requirement of each<br>import item and its justification.<br>i.<br>Percentage yield on molar basis.<br>ii.

Case No.	34 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000405AM23
RA File Number	039404000430 AM21
Licence No and Date	0310838379/21/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for review of norms and as per the details now furnished, it was decided

The Committee considered the request of firm for review of norms and as per the details now furnished, it was decided

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

19

UDIN00158429AM23

to revise adhoc norms as under:

to revise adhoc nor		ms as under:
	Export product		Qty.	Sl. No.	Import items	Qty.
	PERINDOPRIL	ERBUMINE	<br>1 kg	1	S-(-)-INDOLINE-2-CARBOXYLIC	Not recommended
	(PERINDOPRIL ARGININE)				ACID
				2	L-NORVALINE	Not recommended
				3	ACETONITRILE	3.90 kg
				4	NN-CARBONYLDIIMIDAZOLE	064 kg
					,	.
				5	(S)-2-CARBOXY<br>OCTAHYDROINDOLE	0.60 kg
				6	N-[(S)-ETHOXYCARBONYL -1-<br>	0.85 kg
					BUTYL)-(S)-ALANINE
				7	METHYLENE CHLORIDE (MDC)	6.15 kg
RA concerned may take further necessary action as per above decision of NC.<br>8<br>SODIUM PYRUVATE<br>Not recommended<br>9<br>METHANOL<br>Not required in the<br>process				8	SODIUM PYRUVATE	Not recommended
				9	METHANOL	Not required in the<br>process

Case No.	35 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	SIDMAK LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001682AM21
RA File Number	522404000047 AM21
Licence No and<br>Date	5210043542/22/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

20

UDIN00158429AM23

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	Minocycline<br>Hydrochloride<br>Capsules / Tablets 50 mg (Each<br>Capsule/Tablet<br>contains<br>Minocycline 50mg.(Equivalent to<br>Minocycline<br>Hydrochloride<br>53.98mg.<br>)<br>Pharmaceutical<br>Formulations / Standard Grade)<br>(Equivalent to 32.388Kg of bulk<br>drug))	<br> <br> <br> <br> <br> <br> <br> <br>1 Number	1	Minocycline Hydrochloride	55.06 mg
2	Minocycline<br>Hydrochloride<br>Capsules / Tablets 100 mg (Each<br>Capsule/Tablet<br>contains<br>Minocycline 100mg.(Equivalent to<br>Minocycline<br>Hydrochloride<br>107.97mg.<br>)<br>Pharmaceutical<br>Formulations / Standard Grade)<br>(Equivalent to 712.602Kg of bulk<br>drug)<br>Total<br>Bulk<br>Drug<br>Qty.<br>744.990Kg.)	<br> <br> <br> <br> <br> <br> <br> <br> <br>1 Number	1	Minocycline Hydrochloride	110.12 mg

Case No.	36 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	MANKIND PHARMA LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001688AM21
RA File Number	052404000308 AM21
Licence No and Date	0510415295/23/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Feb/202122/14 dated 21.02.2022 against advance authorization No.0510414600 dt.<br>10.07.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Feb/202122/14 dated 21.02.2022 against advance authorization No. 0510414600 dt. 10.07.2020 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

21

UDIN00158429AM23

Sl.<br>No.<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ACETAZOLAMIDE TABLETS, 125<br>MG<br>1 Number<br>1<br>ACETAZOLAMIDE USP<br>127.50 mg<br>2<br>ACETAZOLAMIDE TABLETS, 250<br>MG<br>1 Number<br>2<br>ACETAZOLAMIDE USP<br>255.00 mg<br>RA concerned may take further necessary action as per above decision of NC.	Sl.<br>No.	Export Product	Qty.	Sl. No.	Import items	Qty.
	1	ACETAZOLAMIDE TABLETS, 125<br>MG	<br>1 Number	1	ACETAZOLAMIDE USP	127.50 mg
	2	ACETAZOLAMIDE TABLETS, 250<br>MG	<br>1 Number	2	ACETAZOLAMIDE USP	255.00 mg

Case No.	37 / NC/3/MEET/May/202223/4
Case Status	Case Rejected
Party Name	SRI CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000336AM23
RA File Number	042404000109 AM21
Licence No and<br>Date	0410167147/07/10/2020
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm has not<br>furnished any technical details in support of its request<br>.<br>In view of above, the Committee decided torejectthe case.<br>RA concerned may take further necessary action as per above decision of NC.

The Committee considered the request of firm for fixation of adhoc norms and it was observed that the firm has not furnished any technical details in support of its request

Case No.	38 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	BELCHEM INDUSTRIES (INDIA) PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001738AM21
RA File Number	039404000504 AM21
Licence No and<br>Date	0310838842/13/10/2020
Norms Committee Decision:<br>The Committee considered the case as per and reply received from the firm on DGFT Back Office Portal and it was<br>observed that the reply furnished by the firm is not readable. Hence, it was decided to again call for following

The Committee considered the case as per and reply received from the firm on DGFT Back Office Portal and it was observed that the reply furnished by the firm is not readable. Hence, it was decided to again call for following

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

22

UDIN00158429AM23

information/documents from the firm:

• i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

• (ii) Stoichiometric balance, molecular weight, percentage yield at every stage of reaction.

Case No.	39 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001771AM21
RA File Number	022404000094 AM21
Licence No and<br>Date	0210210167/20/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
COA of import item from foreign supplier.<br>i.
Past Production / Consumption data duly certified by GST Authorities.<br>ii.

Case No.	40 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	INNOVARE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001770AM21
RA File Number	262404000018 AM21
Licence No and<br>Date	2610012921/20/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Please specify export item with structure and molecular weight.<br>i.

Case No.	41 / NC/3/MEET/May/202223/4
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

23

UDIN00158429AM23

Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001793AM21
RA File Number	052404000372 AM21
Licence No and<br>Date	0510415667/28/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>PREDNISOLONE MICRONISED<br>(Partich size less than 30 micron)<br>1 kg<br>1<br>PREDNISOLONE<br>(Partich size 99% < 120 µm)<br>1 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	Case No.	42 / NC/3/MEET/May/202223/4	42 / NC/3/MEET/May/202223/4	42 / NC/3/MEET/May/202223/4	42 / NC/3/MEET/May/202223/4	42 / NC/3/MEET/May/202223/4
Case Status			Case Approved
Party Name			ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			018205001801AM21
RA File Number			342404000205 AM21
Licence No and<br>Date			3410046497/28/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Clobetasol Propionate Cream USP 0.05% 15 gm<br>( net content of active ingredients 225.00 gm. )<br>30000<br>Number<br>Clobetasol Propionate Cream USP 0.05% 30 gm 7009<br>2<br>1<br>Clobetasol<br>Propionate<br>USP<br>(Micronized)<br>5000.180 gram
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Clobetasol Propionate Cream USP 0.05% 15 gm<br>( net content of active ingredients 225.00 gm. )		<br>30000<br>Number	1	Clobetasol<br>Propionate<br>USP<br>(Micronized)	<br>5000.180 gram
	2	Clobetasol Propionate Cream USP 0.05% 30 gm		7009

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

24

UDIN00158429AM23

3<br>4<br>5<br>6<br>7<br>8<br>9	3<br>4<br>5<br>6<br>7<br>8<br>9	( net content of active ingredients 105.135 gm. )	( net content of active ingredients 105.135 gm. )	Number
		Clobetasol Propionate Cream USP 0.05% 45 gm<br>( net content of active ingredients 191.25 gm. )		<br>8500<br>Number
		Clobetasol Propionate Cream USP 0.05% 60 gm<br>( net content of active ingredients 1200.00 gm. )		<br>40000<br>Number
		Clobetasol Propionate Topical Solution USP<br>0.05% 25ml net content of active ingredients<br>625.00 gm. )		<br> <br>50000<br>Number
		Clobetasol Propionate Topical Solution USP<br>0.05% 50 ml net content of active ingredients<br>90000		<br> <br>36000<br>Number
		. gm. )
		Clobetasol Propionate Topical Shampoo, 0.05%<br>118 ml ( net content of active ingredients		<br> <br>19767<br>Number
		<br>1166.253 gm.)		<br>
		Clobetasol Propionate Spray, 0.05% - 59 ml		6000
		<br>( net content of active ingredients 177.00 gm.)		Number
		Clobetasol Propionate Spray, 0.05% - 125 ml net		<br>5000
content of active ingredients 312.500 gm.)<br>Number<br>RA concerned may take further necessary action as per above decision o		content of active ingredients 312.500 gm.)		Number
	oncerned may take further necessary action as per above decision o					f NC.
Case	No.		43 / NC/3/MEET/May/202223/4
Case	Status		Case Deferred
Party	Name		OPTIMUS DRUGS PRIVATE LIMITED
Meet<br>and D	ing Number<br>ate		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ F	ile Number		018205001804AM21
RA F	ile Number		092404000388 AM21
Licen<br>Date
	ce No and		0910069417/29/10/2020
Norm<br>The<br>from	s Committee Decision:
	<br>Committee considered the case as per agenda and it was decided to call for following information / documents<br>the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

25

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(i) Percentage yield on molar basis for each step of manufacturing process.

Justification for requirement of import item No. 2 to 6 with reaction details.

Case No.	44 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	OPTIMUS DRUGS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001805AM21
RA File Number	092404000389 AM21
Licence No and<br>Date	0910069418/29/10/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
(i) Percentage yield on molar basis for each step of manufacturing process.
Justification for requirement of import item No. 2 to 6 with reaction details

Case No.<br>45 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM REVIW00000133AM23
RA File Number<br>342404000202 AM21
Licence No and<br>Date<br>3410046526/05/11/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
Sl. No. Export product<br>Qty.	Sl. No.	Import items	Qty.
1<br>PHENOL<br>4859 MT	1	CUMENE	4286 MT
2<br>ACETONE<br>2964 MT	2	CUMENE	2614 MT

Case No.<br>45 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM REVIW00000133AM23
RA File Number<br>342404000202 AM21
Licence No and<br>Date<br>3410046526/05/11/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify adhoc norms
under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
Sl. No. Export product<br>Qty.	Sl. No.	Import items	Qty.
1<br>PHENOL<br>4859 MT	1	CUMENE	4286 MT
2<br>ACETONE<br>2964 MT	2	CUMENE	2614 MT

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

26

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Case No.	Case No.	46 / NC/3/MEET/May/202223/4	46 / NC/3/MEET/May/202223/4	46 / NC/3/MEET/May/202223/4	46 / NC/3/MEET/May/202223/4	46 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		TIDE INDUSTRIES
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		018205001835AM21
RA File Number		342404000204 AM21
Licence No and<br>Date		3410046524/05/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202021/4 dated 12.02.2021 against advance authorization No.3410045200 dt.<br>10.06.2019, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export Product<br>Qty<br>Sl. No. Import Items<br>Qty<br>1<br>Hexyl Alcohol or N-Hexanol<br>0.90 kg<br>2<br>Acrylic Acid<br>0.66 kg<br>Gamma Nonalactone or Aldehyde<br>C18<br>1 kg<br>3<br>Di-tert Butyl Peroxide<br>0.229 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty	Sl. No.	Import Items	Qty
	Gamma Nonalactone or Aldehyde<br>C18		1 kg	1	Hexyl Alcohol or N-Hexanol	0.90 kg
				2	Acrylic Acid	0.66 kg
				3	Di-tert Butyl Peroxide	0.229 kg
				as per above decision of NC.

Case No.	47 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000390AM23
RA File Number	022404000099 AM21
Licence No and<br>Date	0210210204/09/11/2020

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

27

UDIN00158429AM23

Norms Committee Decision:

The Committee considered the request of firm for enhancement of norms and it was decided to call for following information / documents from the firm:

• i. COA of import item from foreign supplier for the relevant import.

Past Production / Consumption data for last three years duly certified by Central Taxes & GST Authorities.

Case No.	48 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	018205001853AM21
RA File Number	342404000223 AM21
Licence No and<br>Date	3410046549/13/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
COA of import item Nystatin USP from foreign supplier.<br>i.
Justification for arriving at net content in export products and wastage applied

Case No.	Case No.	49 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and	17/06/2022
HQ File Number		HQRNORM REVIW00000231AM23
RA File Number		31AA04005358 AM21
Licence No and<br>Date		3111000104/21/01/2021
Norms Committee Decision:
The Committee considered the request of firm for review of norms and it was observed that due to oversight, earlier
the quantity of import item No. 1 - Mono Ethanol Amine, was reduced to 0.184 kg. Hence, the Committee decided to
revise adhoc norms as under:
	Export product	Qty.<br>Sl. No.		Import items	Qty.

Case No.	Case No.	49 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and	17/06/2022
HQ File Number		HQRNORM REVIW00000231AM23
RA File Number		31AA04005358 AM21
Licence No and<br>Date		3111000104/21/01/2021
Norms Committee Decision:
The Committee considered the request of firm for review of norms and it was observed that due to oversight, earlier
the quantity of import item No. 1 - Mono Ethanol Amine, was reduced to 0.184 kg. Hence, the Committee decided to
revise adhoc norms as under:
	Export product	Qty.<br>Sl. No.		Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

28

UDIN00158429AM23

DIETHYLENETRIAMINE	1 kg	1	MONO ETHANOL AMINE	1.184 kg
(ORGANIC CHEMICAL)
		2	AMMONIA ANHYDROUS	0.165 kg

Case No.	50 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00000228AM23
RA File Number	31AA04006051 AM21
Licence No and<br>Date	3111000148/09/02/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Stoichiometric balance on the basis of molecular weight and percentage yield of reaction.<br>i.
If Ammonia Anhydrous is procured from indigenous source, then why it is indicated in the licence

Case No.<br>51 / NC/3/MEET/May/202223/4
Case Status<br>Case Deferred
Party Name<br>BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM REVIW00000226AM23
RA File Number<br>31AA04006435 AM21
Licence No and<br>Date<br>3111000179/08/03/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call for following information
/ documents from the firm:
Stoichiometric balance on the basis of molecular weight and percentage yield of reaction to arrive at the<br>i.
quantity of raw material asked for.

• i. Stoichiometric balance on the basis of molecular weight and percentage yield of reaction to arrive at the quantity of raw material asked for.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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UDIN00158429AM23

Case No.<br>52 / NC/3/MEET/May/202223/4	Case No.<br>52 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>RENOWN PHARMACEUTICALS PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00117718AM21
RA File Number<br>34AA04003342 AM21
Licence No and Date<br>3411000346/31/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to			ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
Soft Gelatin Capsule Shells (330 mg to 370 mg)	<br>62250420	1	Gelatin 175 Bloom 5-15	<br>25295 kg
(ITC(HS)<br>Code	<br>Number		Mesh
30045090/30045039/30049090/30049099) (Net
Content:<br>Gelatin<br>175<br>Bloom<br>5-15
Mesh:25760.00 KGS)
RA concerned may take further necessary action as per above decision of NC.

Case No.	53 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00117194AM21
RA File Number	09AA04006983 AM21
Licence No and<br>Date	0911000644/31/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of DML.<br>i.
Copy of Master Batch Formula for export item.<br>ii.

Case No.	54 / NC/3/MEET/May/202223/4
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

30

UDIN00158429AM23

Party Name<br>SENTISS PHARMA PRIVATE LIMITED	Party Name<br>SENTISS PHARMA PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00117330AM21
RA File Number<br>05AA04043417 AM21
Licence No and<br>Date<br>0511002009/31/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda	and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
Export product	Qty.	Sl. No.	Import items	Qty.
Brimonidine Tartrate 0.1 Percent Eye Drops	<br>166667	1	Brimonidine Tartrate USP	0.85 kg
Solution 5ml Santabrim	Vials
RA concerned may take further necessary action as per above decision of			NC

Case No.	55 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00117574AM21
RA File Number	09AA04005560 AM21
Licence No and<br>Date	0911000476/31/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of DML.<br>i.
Copy of Master Batch Formula.<br>ii.

Case No.	56 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	VIBRANT PHARMACHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

31

UDIN00158429AM23

HQ File Number	HQRNORM APPLY 00000295AM22
RA File Number	07AA04011201 AM21
Licence No and<br>Date	0711000825/01/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete and balanced chemical reactions with molecular of each reactant, molar requirement of each<br>import item and its justification.<br>i.<br>Percentage yield on molar basis.<br>ii.

Case No.	57 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00000680AM22
RA File Number	30AA04006198 AM21
Licence No and<br>Date	3011000463/01/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis may be furnished in line with<br>Annexure to Appendix 4E.<br>i.

• i. Complete chemistry, molecular weight and percentage yield on molar basis may be furnished in line with Annexure to Appendix 4E.

Case No.	58 / NC/3/MEET/May/202223/4
Case Status	Case Rejected
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00000740AM22
RA File Number	05AA04041798 AM21
Licence No and<br>Date	0511001982/01/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the import item is disproportionally high<br>with respect to export and for that the firm has not given any technical justification.<br>In view of above, the Committee decided torejectthe case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

32

UDIN00158429AM23

Case No.	59 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00004824AM22
RA File Number	05AA04000952 AM22
Licence No and<br>Date	0511002092/06/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that inspite of two deficiency letters; the<br>information given by the firm is incomplete. The yields now given are low and do not match with reaction-<br>sequencing. Technical specification of main raw materials also not given. Hence, the Committee decided to call firm<br>for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	Case No.	60 / NC/3/MEET/May/202223/4	60 / NC/3/MEET/May/202223/4	60 / NC/3/MEET/May/202223/4	60 / NC/3/MEET/May/202223/4	60 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		BAROQUE PHARMACEUTICALS PVT LTD
Meeting Number and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		HQRNORM APPLY 00007930AM22
RA File Number		08AA04012530 AM21
Licence No and Date		0811001119/09/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>GLUCOSAMINE SULFATE<br>SODIUM CHLORIDE<br>6405.6 kg<br>GLUCOSAMINE SULFATE 500MG &<br>CHONDROITIN<br>SULFATE<br>400MG<br>TABLET(GLUCOSAMINE SULFATE<br>500MG & CHONDROITIN SULFATE<br>400MG<br>TABLET<br>(EACH<br>TABLET<br>CONTAINING<br>GLUCOSAMINE<br>SULFATE SODIUM CHLORIDE 628 MG<br>AND<br>CHONDROITIN<br>SULPHATE<br>SODIUM 431 MG))<br>10,000,000<br>Number<br>2<br>CHONDROITIN SULFATE<br>SODIUM<br>4396.2 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	GLUCOSAMINE SULFATE 500MG &<br>CHONDROITIN<br>SULFATE<br>400MG<br>TABLET(GLUCOSAMINE SULFATE<br>500MG & CHONDROITIN SULFATE<br>400MG<br>TABLET<br>(EACH<br>TABLET<br>CONTAINING<br>GLUCOSAMINE<br>SULFATE SODIUM CHLORIDE 628 MG<br>AND<br>CHONDROITIN<br>SULPHATE<br>SODIUM 431 MG))		<br> <br> <br> <br> <br> <br> <br>10,000,000<br>Number	1	GLUCOSAMINE SULFATE<br>SODIUM CHLORIDE	<br>6405.6 kg
				2	CHONDROITIN SULFATE<br>SODIUM	<br>4396.2 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

33

UDIN00158429AM23

Case No.	61 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00019535AM22
RA File Number	09AA04000085 AM22
Licence No and<br>Date	0911000683/15/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Percentage yield of reaction at every step.<br>i.
Copy of earlier norms approved.<br>ii.

Case No.	62 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00020260AM22
RA File Number	34AA04000021 AM22
Licence No and<br>Date	3411000455/16/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Justification for 10% wastage as indicated in Appendix 4E.<br>i.
Details of indigenous input, i.e. Vegetable Fat.<br>ii.
COA of each export item giving net content of each input.<br>iii.

Case No.	63 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

34

UDIN00158429AM23

a	nd Date
H	Q File Number	HQRNORM APPLY			00021691AM22
R	A File Number	05AA04002818 AM2			2
L<br>D	icence No and	0511002233/19/04/20			21
	ate
N<br>T<br>V	orms Committee Decision:<br>he Committee considered the case a<br>ol. I as per details given below or a			s<br>s a	per agenda and it<br>pplied by the fir		was deci<br>m, whiche	ded to ratify adhoc norms under<br>ver is less:		Para 4.07 of HBP
	Export product		Qty.	Sl. No.		Import items			Qty.
	VALPROIC ACID		1 kg	1		DIETHYL MALONATE			1.42 kg
				2		N-PROPYL BROMIDE			2.186 kg
				3		SODIUM HYDROXIDE FLAKES			0.88 kg
				4		TETRA BUTYL AMMONIUM BROMIDE			0.100 kg
				5		SULPHURIC ACID			Not an imortable
									p<br>item
RA concerned may		take further necessary action as per above decision of NC
Case No.		64 / NC/3/MEET/May/202223/4
Case Status		Case Deferred
Party Name		R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
and Date
HQ File Number		HQRNORM APPLY 00023689AM22
RA File Number		07AA04002023 AM22
Licence No and<br>Date		0711000922/21/04/2021
Norms Committee Decision:
Deferred for comments of TE.
Case No.		65 / NC/3/MEET/May/202223/4
Case Status		Case Deferred

Case No.	64 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00023689AM22
RA File Number	07AA04002023 AM22
Licence No and<br>Date	0711000922/21/04/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	65 / NC/3/MEET/May/202223/4
Case Status	Case Deferred

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

35

UDIN00158429AM23

Party Name	GARUDA CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00024406AM22
RA File Number	03AA04031910 AM21
Licence No and<br>Date	0311003270/22/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

Case No.<br>66 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>ALKALOIDS CORPORATION
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00025210AM22
RA File Number<br>02AA04001824 AM22
Licence No and<br>Date<br>0211000589/23/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022 against advance authorization No.
0210207932 dt. 02.11.2017, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or
as applied by the firm, whichever is less: :
Export product<br>Qty.<br>Sl. No. Import items	Qty.
Digoxin<br>1 kg<br>1<br>Digitalis Lanata Leaves (Dried)	436.525 kg
(Digoxin content NMT 0.3%)
RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

36

UDIN00158429AM23

Case No.<br>67 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00026336AM22
RA File Number<br>09AA04001513 AM22
Licence No and<br>Date<br>0911000730/26/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and	taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Oct/202122/10 dated 12.11.2021 against advance authorization No.0311004164 dt.
31.05.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by
the firm, whichever is less:
Export Product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>Tolvaptan(pharmaceutical product)<br>1 kg	7-Chloro-1,2,3,4-tetrahydro-5H-1-Benzazepin-5-one	0.96 kg
2	4-Nitro-2-methyl Benzoic Acid	1.00 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	68 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00027780AM22
RA File Number	07AA04000758 AM22
Licence No and<br>Date	0711000991/27/04/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>ii.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

37

UDIN00158429AM23

stage wise percentage yields on molar basis.

• iii. Complete technical details as per Annexure to Appendix 4E for chemical products.

• iv. Stoichiometric balance between import and export on molar basis.

• v. Production / Consumption data duly certified by GST for the year 2018-19, 2019-20.

• vi. Justification for 27.32% and 41.86% wastage for Glycerine and Magnesium Hydrochloride.

Case No.	69 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00027802AM22
RA File Number	07AA04002553 AM22
Licence No and<br>Date	0711000992/27/04/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	70 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00027804AM22
RA File Number	07AA04002549 AM22
Licence No and<br>Date	0711000993/27/04/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	71 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00028506AM22
RA File Number	07AA04002556 AM22
Licence No and<br>Date	0711001000/28/04/2021
Norms Committee Decision:
Deferred for comments of TE.

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

38

UDIN00158429AM23

Case No.	72 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00028425AM22
RA File Number	08AA04001824 AM22
Licence No and<br>Date	0811001352/28/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the norms for subject Advance<br>Authorization have already been ratified by NC-3 in its Meeting No.NC/3/MEET/Jun/202122/2 dated02/07/2021.<br>In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that the norms for subject Advance Authorization have already been ratified by NC-3 in its Meeting No. NC/3/MEET/Jun/202122/2 dated 02/07/2021 .

Case No.	73 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	BHAGWATI INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00029214AM22
RA File Number	08AA04001833 AM22
Licence No and<br>Date	0811001364/29/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Production / Consumption data duly certified by GST for the year 2018-19, 2019-20.<br>v.<br>End use of export product.<br>vi.

Case No.	74 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00029824AM22
RA File Number	03AA04003827 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

39

UDIN00158429AM23

Licence No and 0311003447/30/04/2021 Date Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

• i. Description of all Excipients shown in items to be imported may be furnished as per their chemical name.

• ii. Details of Packaging Material may be furnished.

• iii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export.

Case No.	Case No.	75 / NC/3/MEET/May/202223/4	75 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		KALKI HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		HQRNORM APPLY 00031354AM22
RA File Number		34AA04000999 AM22
Licence No and<br>Date		3411000521/03/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP
Vol. I as per details given below or as applied by the firm, whichever is less:
	Export product		Qty.	Sl. No.	Import items	Qty.
	S-(+)-2-Aminobutyramide<br>Hydrochloride		<br>1 kg	1	PROPIONALDEHYDE	1.66 kg
	(SABAM HCL)
RA concerned may take further necessary action as per above decision of NC.

Case No.	76 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	CLARIANT INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00032203AM22
RA File Number	03AA04009823 AM22
Licence No and	0311003530/04/05/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

40

UDIN00158429AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and reply furnished by the firm. It was observed that the reply furnished by the firm was not proper. Hence, it was decided to again call for following information / documents from the firm:

• (i) Percentage yield at every stage of reaction.

• (ii) Justification for quantity of import asked on the basis of Stoichiometric balance reactions

Case No.	Case No.	77 / NC/3/MEET/May/202223/4	77 / NC/3/MEET/May/202223/4
Case Status		Case Approved
Party Name		GRAMEN BOTANICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number		HQRNORM APPLY 00032213AM22
RA File Number		05AA04005603 AM22
Licence No and<br>Date		0511002405/04/05/2021
Norms Committee Decision:
The Committee considered the case as per			agenda and it was decided to ratify norms under			Para 4.07 of HBP Vol. I
as per details given below or as applied by			the firm, whichever is less:
	Export product		Qty.<br>Sl. No.	Import items			Qty.
	BERBERINE HYDROCHLORIDE		1 kg<br>1	BERBERIS	ARISTATA	EXTRACT	<br>1.00 kg
				(Assay 90% +/- 1%)
	(97 PERCENT)
RA concerned may take further necessary action as per above decision of NC.

Case No.	78 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00032713AM22
RA File Number	05AA04009888 AM22
Licence No and<br>Date	0511002414/04/05/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

41

UDIN00158429AM23

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

• i. Complete and balanced chemical reactions with molecular weight and percentage yield on molar basis.

• ii. Stepwise material balance.

• iii. Requirement and recovery of solvent of each step.

• iv. Past Production / Consumption data for Buprenorphine HCL Bulk Drug.

• v. Wastage applied on tablets from Bulk Drug.

Case No.	79 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SRF LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00033515AM22
RA File Number	05AA04007697 AM22
Licence No and<br>Date	0511002442/05/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Step wise manufacturing process.<br>i.
Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>ii.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.
Stoichiometric balance between import and export on molar basis.<br>iv.
Details of indigenous input with quantity.<br>v.

Case No.	80 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00033649AM22
RA File Number	34AA04000874 AM22
Licence No and<br>Date	3411000530/05/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

42

UDIN00158429AM23

• Step wise manufacturing process.

• i.

• ii. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.

• iii. Complete technical details as per Annexure to Appendix 4E for chemical products.

• iv. Stoichiometric balance between import and export on molar basis.

• Details of indigenous input with quantity.

• v.

• vi. Production / Consumption data duly certified by GST for the year 2018-19, 2019-20 and 2020-21.

• vii. Justification for wastage at each stage of reaction.

Case No.	Case No.	Case No.	Case No.	81 / NC/3/MEET/May/202223/4	81 / NC/3/MEET/May/202223/4	81 / NC/3/MEET/May/202223/4
Case Status				Case Approved
Party Name				GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number				HQRNORM APPLY 00033514AM22
RA File Number				03AA04009664 AM22
Licence No and<br>Date				0311003582/05/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export Product<br>Qty.<br>1<br>FLUCORT N SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>322660 Number<br>2<br>FLUCORT SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>322660 Number<br><br>
	Sl. No.	Export Product				Qty.
	1	FLUCORT N SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)				<br>322660 Number
	2	FLUCORT SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)				<br>322660 Number
	3	F<br>	LUCORT SKIN CREAM 0.025percent (Pack<br>LUOCINOLONE ACETONIDE BP is 0605 Ks)		Size 10 gms) ( Net Wt.of	<br>242000 Number
			. g.
	4		A 25 k		i 5 f
		<br>F	LUCORT SKIN CREM 0.0percent (Pac<br>LUOCINOLONE ACETONIDE BP is 1.210 Kgs.)		Sze gms) ( Net Wt.o	<br>968000 Number
	5	FLUOCINOLONE CREAM (TDR) ET 0.025percent (Pack Size 10 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)				<br>96800 Number
	6	CYNOZ<br>ACETO		ET CREAM 0.025percent (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE<br>NIDE BP i 0242 K)		<br>193600 Number
		s . gs.

Case No.	Case No.	Case No.	Case No.	81 / NC/3/MEET/May/202223/4	81 / NC/3/MEET/May/202223/4	81 / NC/3/MEET/May/202223/4
Case Status				Case Approved
Party Name				GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date				NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number				HQRNORM APPLY 00033514AM22
RA File Number				03AA04009664 AM22
Licence No and<br>Date				0311003582/05/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export Product<br>Qty.<br>1<br>FLUCORT N SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>322660 Number<br>2<br>FLUCORT SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)<br>322660 Number<br><br>
	Sl. No.	Export Product				Qty.
	1	FLUCORT N SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)				<br>322660 Number
	2	FLUCORT SKIN CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)				<br>322660 Number
	3	F<br>	LUCORT SKIN CREAM 0.025percent (Pack<br>LUOCINOLONE ACETONIDE BP is 0605 Ks)		Size 10 gms) ( Net Wt.of	<br>242000 Number
			. g.
	4		A 25 k		i 5 f
		<br>F	LUCORT SKIN CREM 0.0percent (Pac<br>LUOCINOLONE ACETONIDE BP is 1.210 Kgs.)		Sze gms) ( Net Wt.o	<br>968000 Number
	5	FLUOCINOLONE CREAM (TDR) ET 0.025percent (Pack Size 10 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)				<br>96800 Number
	6	CYNOZ<br>ACETO		ET CREAM 0.025percent (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE<br>NIDE BP i 0242 K)		<br>193600 Number
		s . gs.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

43

UDIN00158429AM23

	7	CYNOZ	CYNOZ	ET CREAM 0.025percent (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE	ET CREAM 0.025percent (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE	<br>64532 Number
		ACETO		NIDE BP is 0.242 Kgs.)
	8	SUPRIC<br>FLUOC		ORT<br>CREAM<br>0.025percent<br>(Pack<br>Size<br>5<br>gms)<br>(<br>Net<br>Wt.of<br>INOLONE ACETONIDE BP is 0.726 Kgs.)		<br>580800 Number
	9	SUPRICORT<br>CREAM<br>0.025percent<br>(Pack<br>Size<br>15<br>gms)<br>(<br>Net<br>Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.)				<br>193596 Number
	10	SUPRICORT CREAM 0.025percent (Pack Size 250 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.242 Kgs.)				<br>3873 Number
	11	SUPRICORT N CREAM 0.025percent (Pack Size 5 gms) ( Net Wt.of				<br>193600 Nb
		FLUOC		INOLONE ACETONIDE BP is 0.242 Kgs. )		umer
	12	SUPRIC		ORT N CREAM 0.025percent (Pack Size 15 gms) ( Net Wt.of		<br>
		<br>FLUOC		<br>INOLONE ACETONIDE BP is 0.242 Kgs.)		<br>64532 Number
	13	Flucort<br>ACETO		C Cream 0.01percent (Pack Size 15 gms) (Net Wt.of FLUOCINOLONE<br>NIDE BP i 0095 K		<br>63332 Number
				s . gs)
	14	FLUCORT C OINTMENT 0.025percent (Pack Size 15 gms) ( Net Wt.of<br>FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)				<br>161330 Number
	15	GLENCORT GEL 0.025percent (Pack Size 5 gms) (Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.452 Kgs.)				<br>361600 Number
	16	GLENCORT GEL 0.025percent (Pack Size 30 gms) (Net Wt.of FLUOCINOLONE<br>ACETONIDE BP is 0.484 Kgs.)				<br>64535 Number
	17	FLUCO<br>		RT MZ SKIN OINTMENT 0.01percent (Pack Size 15 gms) ( Net Wt.of<br>A i 145		<br>96798 Number
		FLUO		INOLONE CETONIDE BP s 0. Kgs.)
	Sl. No.		Import	Items	Qty
1<br>FLUOCINOLONE ACETONIDE BP<br>9.10 kg	1		FLUOCINOLONE ACETONIDE BP		9.10 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

44

UDIN00158429AM23

Case No.<br>82 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>ALTA LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00033839AM22
RA File Number<br>03AA04011093 AM22
Licence No and<br>Date<br>0311003601/06/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022against advance authorization No.0311008559 dt.
**15.11.2021,**it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by
the firm, whichever is less:
Export product<br>Qty.<br>Sl. No.	Import items	Qty.
1<br>METHYL PARABEN<br>1 kg	Para Hydroxy Benzoic Acid	0.97 kg
2	Methanol	0.50 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	83 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ASTEC LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00036355AM22
RA File Number	03AA04007493 AM22
Licence No and<br>Date	0311003675/09/05/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	84 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	PORUS LABORATORIES PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

45

UDIN00158429AM23

and Date
HQ File Number<br>HQRNORM APPLY 00036920AM22
RA File Number<br>09AA04002104 AM22
Licence No and<br>Date<br>0911000798/10/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Complete technical details as per Appendix 4E.<br>i.
End-use of Export item.<br>ii.
Production / Consumption data duly certified by GST Authorities

Case No.	85 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00038818AM22
RA File Number	03AA04005126 AM22
Licence No and<br>Date	0311003736/12/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Five import items are shown in the licence, whereas only 2 inputs have been shown imported under<br>i.
Appendix 4E. Please clarify it.
Consumption-coefficient of each imported input for API.<br>ii.
Wastage claimed on API to manufacture tablets.<br>iii.

• i. Five import items are shown in the licence, whereas only 2 inputs have been shown imported under Appendix 4E. Please clarify it.

Case No.	86 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00039055AM22
RA File Number	05AA04009662 AM22
Licence No and<br>Date	0511002560/12/05/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

46

UDIN00158429AM23

The Committee considered the case as per agenda and it was observed that each injection is having potency of 25,000 units. However, the firm has applied for total import quantity of 900 units against export of 33,783 injections. No norms can be proposed in its present form.

In view of above discrepancy, it was decided to call firm for attending Personal Hearing before Norms Committee alongwith relevant documents to explain its case.

Case No.	Case No.	Case No.	87 / NC/3/MEET/May/202223/4	87 / NC/3/MEET/May/202223/4	87 / NC/3/MEET/May/202223/4	87 / NC/3/MEET/May/202223/4	87 / NC/3/MEET/May/202223/4
Case Status			Case Approved
Party Name			MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			HQRNORM APPLY 00042233AM22
RA File Number			03AA04013716 AM22
Licence No and<br>Date			0311003840/17/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>PHENOXYMETHYL<br>PENICILLIN<br>TABLETS<br>BP<br>250<br>MG.((Each<br>Tablets<br>contains: Phenoxymethyl Penicillin Potassium<br>equivalent to Phenoxymethyl Penicillin BP<br>250 mg) ( Total Net Content = 6798.898 Kgs ))<br>1 Number<br>1<br>Phenoxymethyl<br>Penicillin<br>Potassium BP<br>277.161 mg<br>2<br>PHENOXYMETHYL<br>PENICILLIN<br>TABLETS 500 MG((Each Tablet contains<br>Phenoxymethyl<br>Penicillin<br>Potassium<br>equivalent to Phenoxymethyl Penicillin BP<br>500mg ) ( Total Net Content = 7799.311 Kgs ))<br>1 Number<br>2<br>Phenoxymethyl<br>Penicillin<br>Potassium BP<br>554.322 mg<br>3<br>PHENOXYMETHYL PENICILLIN ORAL<br>SOLUTION(BP 125 MG/5ML (SYRUP).Each<br>5ml<br>contains:<br>Phenoxymethyl<br>penicillin<br>Potassium<br>equivalent<br>to<br>Phenoxymethyl<br>Penicillin BP 125mg) 100ML Bottle. (Total<br>Net Content = 2633.020 Kgs ))<br>1 Number<br>3<br>Phenoxymethyl<br>Penicillin<br>Potassium BP<br>2771.61 mg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	PHENOXYMETHYL<br>PENICILLIN<br>TABLETS<br>BP<br>250<br>MG.((Each<br>Tablets<br>contains: Phenoxymethyl Penicillin Potassium<br>equivalent to Phenoxymethyl Penicillin BP<br>250 mg) ( Total Net Content = 6798.898 Kgs ))		<br> <br> <br> <br>1 Number	1	Phenoxymethyl<br>Penicillin<br>Potassium BP	<br>277.161 mg
	2	PHENOXYMETHYL<br>PENICILLIN<br>TABLETS 500 MG((Each Tablet contains<br>Phenoxymethyl<br>Penicillin<br>Potassium<br>equivalent to Phenoxymethyl Penicillin BP<br>500mg ) ( Total Net Content = 7799.311 Kgs ))		<br> <br> <br> <br>1 Number	2	Phenoxymethyl<br>Penicillin<br>Potassium BP	<br>554.322 mg
	3	PHENOXYMETHYL PENICILLIN ORAL<br>SOLUTION(BP 125 MG/5ML (SYRUP).Each<br>5ml<br>contains:<br>Phenoxymethyl<br>penicillin<br>Potassium<br>equivalent<br>to<br>Phenoxymethyl<br>Penicillin BP 125mg) 100ML Bottle. (Total<br>Net Content = 2633.020 Kgs ))		<br> <br> <br> <br> <br>1 Number	3	Phenoxymethyl<br>Penicillin<br>Potassium BP	<br>2771.61 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

47

UDIN00158429AM23

4	PHENOXYMETHYL PENICILLIN ORAL	PHENOXYMETHYL PENICILLIN ORAL	<br>1 Number	4	Phenoxymethyl	Penicillin	<br>5543.22 mg
	SOLUTION(BP 250 MG/5ML	(SYRUP).Each			Potassium BP
	5ml<br>contains:<br>Phenoxymethyl<br>penicillin
	Potassium<br>equivalent<br>to	Phenoxymethyl
	Penicillin BP 250mg) 100ML	Bottle. ( Total
	Net Content = 2771.610 Kgs ))

RA concerned may take further necessary action as per above decision of NC

C N	88 / NC/3/MEET/M/202223/4
ase o.	ay
C Stt	C Dfd
ase aus	ase eerre
Pt N	SAURAV CHEMICALS LIMITED
ary ame
Mti Nb
eeng umer<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ Fil Nb	HQRNORM APPLY 00045345AM22
e umer
RA Fil Nb	30AA04001247 AM22
e umer
Li N d
cence o an<br>Date	3011000633/18/05/2021
N Citt	Dii
orms ommee ecson:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis may be furnished in line with<br>Annexure to Appendix 4E.<br>i.

• i. Complete chemistry, molecular weight and percentage yield on molar basis may be furnished in line with Annexure to Appendix 4E.

Case No	89 / NC/3/MEET/Ma/202223/4
.	y
Case Status	Case Aroved
	pp
Part Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
y
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00046861AM22
RA File Number	05AA04016543 AM22
Licence No and<br>Date	0511002719/20/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022 against advance authorization No.0511006111 dt.<br>12.11.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Mar/202122/16 dated 08.04.2022 against advance authorization No. 0511006111 dt. 12.11.2021 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

48

UDIN00158429AM23

Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Meropenem with Sodium Carbonate USP (<br>Meropenem<br>Buffered<br>)(Bulk<br>Drug<br>/<br>Pharmacopeal Grade)<br>1 kg<br>1<br>(4R,5S,6S)-3-[[(3S,5S)-5-<br>(Dimethylcarbamoyl)-3-<br>pyrrolidinyl]thio]-6-[(1R)-1-<br>hydroxyethyl]-4methyl-7-oxo-1-<br>azabicyclo<br>0.8728 kg<br>RA concerned may take further necessary action as per above decision of NC.	Export Product	Qty.	Sl. No.	Import items	Qty.
	Meropenem with Sodium Carbonate USP (<br>Meropenem<br>Buffered<br>)(Bulk<br>Drug<br>/<br>Pharmacopeal Grade)	<br> <br>1 kg	1	(4R,5S,6S)-3-[[(3S,5S)-5-<br>(Dimethylcarbamoyl)-3-<br>pyrrolidinyl]thio]-6-[(1R)-1-<br>hydroxyethyl]-4methyl-7-oxo-1-<br>azabicyclo	0.8728 kg

Case No.	90 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00046900AM22
RA File Number	09AA04002898 AM22
Licence No and<br>Date	0911000881/20/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Percentage yield of reaction at every step.<br>i.<br>Copy of earlier norms approved.<br>ii.

Case No.	91 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	TADIMETY AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00047898AM22
RA File Number	07AA04004515 AM22
Licence No and<br>Date	0711001152/21/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

49

UDIN00158429AM23

• i. Step wise manufacturing process.

• ii. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.

• iii. Complete technical details as per Annexure to Appendix 4E for chemical products.

• iv. Stoichiometric balance between import and export on molar basis.

• v. Details of indigenous input with quantity.

Case No.<br>92 / NC/3/MEET/May/202223/4
Case Status<br>Case Approved
Party Name<br>TATVA CHINTAN PHARMA CHEM LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00047933AM22
RA File Number<br>34AA04001536 AM22
Licence No and<br>Date<br>3411000610/21/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in
Meeting No.15/82-ALC4/2018 dated 22.03.2019 against advance authorization No.3410044276 dt.		22.06.2018, it
was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm,
whichever is less:
Export Product<br>Qty.<br>Sl. No.	Import items	Qty.
METHYL<br>TRIBUTYL<br>AMMONIUM<br>1 kg<br>1	TRIBUTYL AMINE ASSAY NLT 98.5	<br>0.4642 kg
CHLORIDE ASSAY 75 PERCENT (+/-2	PERCENT
PERCENT)
RA concerned may take further necessary action as per above	decision of NC.

Case No.	93 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SAKAR HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00099634AM22
RA File Number	08AA04004104 AM22
Licence No and<br>Date	0811001574/25/05/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

50

UDIN00158429AM23

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

i. COA of import item from foreign supplier showing potency and wastage claimed on it.

Case No.	94 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	DIAMINES AND CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00101253AM22
RA File Number	34AA04001451 AM22
Licence No and<br>Date	3411000643/27/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>COA of import item indicating percentage composition of various amines and other products.<br>i.<br>Quantity and Commercial value of By-Product obtained.<br>ii.<br>Production / Consumption data for last three years duly certified by GST.

Case No.	95 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00102193AM22
RA File Number	08AA04005014 AM22
Licence No and<br>Date	0811001601/28/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

51

UDIN00158429AM23

v. Percentage composition of various Amines used in Export Product.

Case No.	96 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	UNITED MUD-CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00103082AM22
RA File Number	03AA04017853 AM22
Licence No and<br>Date	0311004136/30/05/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Percentage net content of Dimer Acid in Export.

Case No.	97 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00104366AM22
RA File Number	08AA04004876 AM22
Licence No and<br>Date	0811001618/01/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Stoichiometric balance to arrive at the quantity of Methanol asked on the basis of molecular weight, yield etc.

Case No.	98 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00105763AM22
RA File Number	03AA04017165 AM22
Licence No and<br>Date	0311004253/02/06/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

52

UDIN00158429AM23

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

• i. Description of all Excipients shown in items to be imported may be furnished as per their chemical name.

• ii. Details of Packaging Material may be furnished.

• iii. Copy of Master Batch Formula for all export items indicating net content of inputs in each export.

Case No.<br>99 / NC/3/MEET/May/202223/4
Case Status<br>Case Deferred
Party Name<br>TIDE INDUSTRIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number<br>HQRNORM APPLY 00107290AM22
RA File Number<br>34AA04002205 AM22
Licence No and<br>Date<br>3411000694/04/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
End use of export item.<br>i.
Commercial value of Low Boiler & High Boiler and Polymerised Material.<br>ii.
Production / Consumption data for last three years duly certified by GST.

Case No.	100 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00107366AM22
RA File Number	34AA04002212 AM22
Licence No and<br>Date	3411000697/04/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
End use of<br>i.	export item.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

53

UDIN00158429AM23

• ii. Commercial value of Low Boiler & High Boiler and Polymerised Material.

Production / Consumption data for last three years duly certified by GST

Case No.	101 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00107373AM22
RA File Number	03AA04018281 AM22
Licence No and<br>Date	0311004321/04/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>i.
name.
Details of Packaging Material may be furnished.<br>ii.
Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No.	102 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	STERILE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00108212AM22
RA File Number	05AA04019922 AM22
Licence No and<br>Date	0511002989/05/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
COA of Export item..<br>i.
COA of import item from foreign supplier..<br>ii.
Copy of Master Batch Formula.<br>iii.
iv DML for export.

Case No. 103 / NC/3/MEET/May/202223/4

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

54

UDIN00158429AM23

Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00109187AM22
RA File Number	03AA04022509 AM22
Licence No and<br>Date	0311004402/07/06/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	104 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00109350AM22
RA File Number	03AA04023320 AM22
Licence No and<br>Date	0311004415/08/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Density of each export item.<br>i.

Case No.	105 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00109428AM22
RA File Number	34AA04002141 AM22
Licence No and<br>Date	3411000701/08/06/2021
Norms Committee Decision:
Deferred for comments of TE

Case No.	106 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

55

UDIN00158429AM23

and Date
HQ File Number	HQRNORM APPLY 00109478AM22
RA File Number	09AA04003622 AM22
Licence No and<br>Date	0911001018/08/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	107 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00109532AM22
RA File Number	05AA04023341 AM22
Licence No and<br>Date	0511003027/08/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022 against advance authorization No.0511006111 dt.<br>12.11.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Meropenem with Sodium Carbonate USP (<br>Meropenem<br>Buffered<br>)(Bulk<br>Drug<br>/<br>Pharmacopeal Grade)<br>1 kg<br>1<br>(4R,5S,6S)-3-[[(3S,5S)-5-<br>(Dimethylcarbamoyl)-3-<br>pyrrolidinyl]thio]-6-[(1R)-1-<br>hydroxyethyl]-4methyl-7-oxo-1-<br>azabicyclo<br>0.8728 kg<br>RA concerned may take further necessary action as per above decision of NC

Case No.	108 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	FRESENIUS KABI INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00109628AM22
RA File Number	03AA04019238 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

56

UDIN00158429AM23

Licence No and 0311004420/08/06/2021 Date Norms Committee Decision: Deferred for comments of TE.

Case No.	109 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00111363AM22
RA File Number	31AA04004163 AM22
Licence No and<br>Date	3111000397/10/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Percentage purity of export product alongwith COA.<br>i.
Stoichiometric balance on molar basis and percentage yield to arrive at the quantity of raw material asked for.

Case No.	110 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	J B CHEMICALS AND PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00111397AM22
RA File Number	03AA04009888 AM22
Licence No and<br>Date	0311004497/10/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No.
NC/3MEET/Jun/202122/2 dated 02.07.2021against advance authorization No.0311004496 dt. 10.06.2021, it was decided to
ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:
Sl. No.<br>Export Product		Qty.
GLIPIZIDE EXTENDED RELEASE TABLETS 10 MG. Each tablet contains (i) Glipizide USP- 10<br>1		<br>1 Number
mg((ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 29.70 mg (iii) Sentry Polyox WSR N80
FP NF- 178.10 mg (iv) Sentry Polyox WSR 303 NF- 100 mg. Net content (i) 459.46 Kgs (ii) 1364.59

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

57

UDIN00158429AM23

	Kgs (iii) 8182.96 Kgs (iv) 4594.59 Kgs.)
2	GLIPIZIDE EXTENDED RELEASE TABLETS 5 MG. Each tablet contains (i) Glipizide USP- 5	<br>1 Number
	mg((ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80
	FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 182.43 Kgs (ii) 744.32 Kgs
	(iii) 3249.12 Kgs (iv) 1824.33 Kgs.)
3	GLIPIZIDE EXTENDED RELEASE TABLETS 2.5 MG. Each tablet contains (i) Glipizide USP- 2.5	1 Number
	mg((ii) Eastman (TM Cellulose Acetate (CA 398-10NF/EP)- 20.40 mg (iii) Sentry Polyox WSR N80
	FP NF- 89.05 mg (iv) Sentry Polyox WSR 303 NF- 50 mg. Net content (i) 33.78 Kgs (ii) 275.68 Kgs
	(iii) 1203.38 Kgs (iv) 675.68 Kgs.)

Import Items	For export of 1 Number of Tablet	For export of 1 Number of Tablet	For export of 1 Number of Tablet
	2.5 mg	5.0 mg	10.0 mg
GLIPIZIDE USP	2.55 mg	5.10 mg	10.20 mg
EASTMAN (TM) CELLULOSE ACETATE (CA 398-10NF/EP)	20.40 mg	20.40 mg	29.70 mg
SENTRY POLYOX WSR N80 FP NF	89.05 mg	89.05 mg	178.10 mg
SENTRY POLYOX WSR 303 NF	50.00 mg	50.00 mg	100.00 mg

RA may take appropriate action as per the decision of Norms Committee.

Case No.	111 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00112010AM22
RA File Number	03AA04024304 AM22
Licence No and<br>Date	0311004509/10/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022 against advance authorization No.0311005604 dt.<br>29.04.2022, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by

The Committee considered the case as per agenda and taking cue from earlier decision for same export product in Meeting No. NC/3/MEET/Apr/202223/1 dated 29.04.2022 against advance authorization No. 0311005604 dt. 29.04.2022 , it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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the firm, whichever is less:

Export Product	Qty.	Sl. No.	Import items	Qty.
DINONYLATED<br>DIPHENYLAMINE<br>(YALUB DND)	<br>1 kg	1	DIPHENYLAMINE	0.4134 kg
		2	NONENE	0.4 kg
		3	ACTIVATED CLAY	0.05 kg

Case No.	112 / NC/3/MEET/May/202223/4
Case Status	Case Approved
Party Name	TINA ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00112444AM22
RA File Number	05AA04025398 AM22
Licence No and<br>Date	0511003109/11/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product in<br>Meeting No.NC/3/MEET/Jan/202122/13 dated 21.01.2022 against advance authorization No.0510413266 dt.<br>09.01.2020, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ORTHO ISOPROPYL PHENOL<br>0.950 kg<br>ISOPROPYLATED PHENYL PHOSPHATE<br>(LIQUID STANDARD)<br>1 kg<br>2<br>PHOSPHOROUS<br>0.079 kg<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	Case No.	Case No.	113 / NC/3/MEET/May/202223/4	113 / NC/3/MEET/May/202223/4	113 / NC/3/MEET/May/202223/4	113 / NC/3/MEET/May/202223/4	113 / NC/3/MEET/May/202223/4
Case Status			Case Approved
Party Name			COMBITIC GLOBAL CAPLET PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			HQRNORM APPLY 00112558AM22
RA File Number			33AA04001775 AM22
Licence No and<br>Date			3311000287/11/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No.<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Azithromycin Tablet IP/BP/USP 250mg.((Each<br>film<br>coated<br>Tablet<br>Contains<br>267.75mg.<br>Azithromycin Dihydrate IP/BP/USP Equivalent to<br>250mg. Azithromycin))<br>1 Number<br>1<br>Azithromycin Dihydrate IP<br>267.24<br>mg/Tablet<br>2<br>Azithromycin Tablets IP/BP/USP 500mg.((Each<br>film<br>coated<br>Tablet<br>Contains<br>535.50mg.<br>Azithromycin Dihydrate IP/BP/USP Equivalent to<br>500mg. Azithromycin))<br>1 Number<br>2<br>Azithromycin Dihydrate IP<br>534.48<br>mg/Tablet<br>3<br>Azithromycin Dihydrate IP<br>267.24<br>mg/Tablet<br>3<br>Cefixime and Azithromycin Tablets((Each Film<br>Coated Tablet Contains Cefixime Trihydrate IP<br>228.48mg.<br>Equivalent<br>to<br>Cefixime<br>200mg.<br>Azithromycin Dihydrate IP 267.75mg. Equivalent<br>to Azithromycin 250mg.))<br>1 Number<br>6<br>Cefixime Trihydrate IP<br>228.294<br>mg/Tablet<br>4<br>Cefixime Tablets IP/BP/USP 200mg.((Each Film<br>Coated Tablet Contains Cefixime Trihydrate<br>IP/BP/USP 228.48mg. Equivalent to Cefixime<br>200mg.))<br>1 Number<br>4<br>Cefixime Trihydrate IP<br>228.294<br>mg/Tablet<br>5<br>Cefixime Tablets IP/BP/USP 400mg.((Each Film<br>Coated Tablet Contains Cefixime Trihydrate<br>IP/BP/USP 456.96mg. Equivalent to Cefixime<br>400mg.))<br>1 Number<br>5<br>Cefixime Trihydrate IP<br>456.588<br>mg/Tablet
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	Azithromycin Tablet IP/BP/USP 250mg.((Each<br>film<br>coated<br>Tablet<br>Contains<br>267.75mg.<br>Azithromycin Dihydrate IP/BP/USP Equivalent to<br>250mg. Azithromycin))		<br> <br> <br>1 Number	1	Azithromycin Dihydrate IP	267.24<br>mg/Tablet
	2	Azithromycin Tablets IP/BP/USP 500mg.((Each<br>film<br>coated<br>Tablet<br>Contains<br>535.50mg.<br>Azithromycin Dihydrate IP/BP/USP Equivalent to<br>500mg. Azithromycin))		<br> <br> <br>1 Number	2	Azithromycin Dihydrate IP	534.48<br>mg/Tablet
	3	Cefixime and Azithromycin Tablets((Each Film<br>Coated Tablet Contains Cefixime Trihydrate IP<br>228.48mg.<br>Equivalent<br>to<br>Cefixime<br>200mg.<br>Azithromycin Dihydrate IP 267.75mg. Equivalent<br>to Azithromycin 250mg.))		<br> <br> <br> <br>1 Number	3	Azithromycin Dihydrate IP	267.24<br>mg/Tablet
					6	Cefixime Trihydrate IP	228.294<br>mg/Tablet
	4	Cefixime Tablets IP/BP/USP 200mg.((Each Film<br>Coated Tablet Contains Cefixime Trihydrate<br>IP/BP/USP 228.48mg. Equivalent to Cefixime<br>200mg.))		<br> <br> <br>1 Number	4	Cefixime Trihydrate IP	228.294<br>mg/Tablet
	5	Cefixime Tablets IP/BP/USP 400mg.((Each Film<br>Coated Tablet Contains Cefixime Trihydrate<br>IP/BP/USP 456.96mg. Equivalent to Cefixime<br>400mg.))		<br> <br> <br>1 Number	5	Cefixime Trihydrate IP	456.588<br>mg/Tablet

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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Case No.	114 / NC/3/MEET/May/202223/4
Case Status	Case Rejected
Party Name	SAURAV CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00113426AM22
RA File Number	30AA04004647 AM22
Licence No and<br>Date	3011000736/12/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and reply of firm and it was observed that the firm has not given any<br>technical details in its reply.<br>In view of above, the Committee decided torejectthe case.

The Committee considered the case as per agenda and reply of firm and it was observed that the firm has not given any technical details in its reply.

Case No.	115 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00113434AM22
RA File Number	03AA04015087 AM22
Licence No and<br>Date	0311004561/12/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Description of all Excipients shown in items to be imported may be furnished as per their chemical<br>name.<br>i.<br>Details of Packaging Material may be furnished.<br>ii.<br>Copy of Master Batch Formula for all export items indicating net content of inputs in each export.<br>iii.

Case No.	116 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM APPLY 00113697AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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UDIN00158429AM23

RA File Number	31AA04007148 AM21
Licence No and<br>Date	3111000400/14/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Step wise manufacturing process.<br>i.<br>Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>stage wise percentage yields on molar basis.<br>ii.<br>Complete technical details as per Annexure to Appendix 4E for chemical products.<br>iii.<br>Stoichiometric balance between import and export on molar basis.<br>iv.<br>Details of indigenous input with quantity.<br>v.<br>Production / Consumption data duly certified by GST for the year 2018-19, 2019-20 and 2020-21.<br>vi.<br>Percentage purity of export product alongwith its COA.<br>vii.

Case No.	Case No.	Case No.	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4
Case Status			Case Approved
Party Name			MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			HQRNORM APPLY 00163823AM22
RA File Number			03AA04064805 AM22
Licence No and Date			0311006209/16/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ERYTHROMYCIN<br>TABLETS<br>250<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 413.25<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 250 mg) (Net content / Tablet-<br>413.250 mg.Total Net wt = 4580.050 Kgs<br>11083000<br>Number<br>1<br>ERYTHROMYCIN<br>STEARATE EP / CEP<br>4580.05 kg<br>ERYTHROMYCIN<br>TABLETS<br>500<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 826.50<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 500 mg) (Net content / Tablet-<br>2<br>1755000<br>Number<br>2<br>ERYTHROMYCIN<br>STEARATE EP / CEP<br>1450.5 kg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	ERYTHROMYCIN<br>TABLETS<br>250<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 413.25<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 250 mg) (Net content / Tablet-<br>413.250 mg.Total Net wt = 4580.050 Kgs		<br> <br> <br> <br> <br>11083000<br>Number	1	ERYTHROMYCIN<br>STEARATE EP / CEP	4580.05 kg
	2	ERYTHROMYCIN<br>TABLETS<br>500<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 826.50<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 500 mg) (Net content / Tablet-		<br> <br> <br> <br> <br>1755000<br>Number	2	ERYTHROMYCIN<br>STEARATE EP / CEP	1450.5 kg

Case No.	Case No.	Case No.	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4	117 / NC/3/MEET/May/202223/4
Case Status			Case Approved
Party Name			MILAN LABORATORIES (INDIA) PRIVATE LIMITED
Meeting Number and<br>Date			NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number			HQRNORM APPLY 00163823AM22
RA File Number			03AA04064805 AM22
Licence No and Date			0311006209/16/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ERYTHROMYCIN<br>TABLETS<br>250<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 413.25<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 250 mg) (Net content / Tablet-<br>413.250 mg.Total Net wt = 4580.050 Kgs<br>11083000<br>Number<br>1<br>ERYTHROMYCIN<br>STEARATE EP / CEP<br>4580.05 kg<br>ERYTHROMYCIN<br>TABLETS<br>500<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 826.50<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 500 mg) (Net content / Tablet-<br>2<br>1755000<br>Number<br>2<br>ERYTHROMYCIN<br>STEARATE EP / CEP<br>1450.5 kg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	ERYTHROMYCIN<br>TABLETS<br>250<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 413.25<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 250 mg) (Net content / Tablet-<br>413.250 mg.Total Net wt = 4580.050 Kgs		<br> <br> <br> <br> <br>11083000<br>Number	1	ERYTHROMYCIN<br>STEARATE EP / CEP	4580.05 kg
	2	ERYTHROMYCIN<br>TABLETS<br>500<br>MG((Each<br>Tablets<br>contains:<br>ERYTHROMYCIN STEARATE 826.50<br>mg equivalent to ERYTHROMYCIN BP<br>/PH Eur 500 mg) (Net content / Tablet-		<br> <br> <br> <br> <br>1755000<br>Number	2	ERYTHROMYCIN<br>STEARATE EP / CEP	1450.5 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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826.500 mg.Total Net wt = 1450.508 Kgs)

Case No.	118 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00397092AM22
RA File Number	08AA04023464 AM22
Licence No and<br>Date	0811002450/31/08/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call firm for attending
Personal Hearing	<br> before Norms Committee alongwith relevant documents to explain its case

Case No.	119 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00397104AM22
RA File Number	08AA04025507 AM22
Licence No and<br>Date	0811002517/06/09/2021
Norms Committee Decision:
The Committee considered the request of firm for enhancement of norms and it was decided to call firm for attending
Personal Hearing	<br> before Norms Committee alongwith relevant documents to explain its case

Case No.	120 / NC/3/MEET/May/202223/4
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ May/ 202223/ 4 and 17/06/2022
HQ File Number	HQRNORM REVIW00397111AM22
RA File Number	08AA04030678 AM22
Licence No and<br>Date	0811002770/04/10/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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The Committee considered the request of firm for enhancement of norms and it was decided to call firm for attending Personal Hearing before Norms Committee alongwith relevant documents to explain its case

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 20-Jul-2022 13:06:31 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

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